Promising portable kidney faces innovation, portability bottlenecks

AK 98 in foreground with woman and man on sofa

This article is part of our special report Europe’s ‘decade of the kidney’.

Portable artificial kidney is perceived as the next big thing in the field of home treatment that could stop dialysis being a full-time job for patients, but barriers to its rollout persist.

In a recent study, more than 1,500 health specialists surveyed about their perceptions of the future of kidney replacement therapies considered portable/wearable kidney as one of the best viable technology together with implantable solutions.

The main concept behind portable/wearable kidneys is to promote autonomy and self-caring, meaning the possibility for patients to adapt their kidney disease treatment to their lives.

But according to Jasper Boomker from the Dutch Kidney Foundation, there is a deadlock preventing the rollout of these devices since established dialysis providers have no incentive to change the business model.

“Home dialysis is not yet actively promoted by doctors as the current clinic-based business model is still profitable,” Boomker told EURACTIV.

Only patients who are relatively fit and independent, he added, do home hemodialysis, although many of the hospital dialysis patients would be able to dialyse at home with some sort of professional support.

On top of that, several national reimbursement systems do not yet seem ready to accommodate the broad rollout of home treatment, though policymakers often stress the necessity to make home healthcare more feasible.

In 2016, over 80% of households in ten member states reported difficulty in covering the costs of professional home care services, in particular in Slovakia (95%), Lithuania (94%) and Greece (93%), according to the EU’s statistical service EUROSTAT

On the other hand, the highest shares of households that could pay for these services with ease were found in Finland (75%), Sweden (73%) and Denmark (69%).

Commission: burden of levelling kidney treatment access falls mainly on member states

While inequalities across the EU when it comes to kidney disease treatments are well-known by the European Commission, the ball is ultimately in member states’ courts when it comes to expanding access, according to health stakeholders.

Innovation paradox

For Fokko Wieringa, a Dutch engineer associate professor of medical technology at  Utrecht University, the development of medical devices is laborious and expensive as it is costly to invest in multiple candidate products, each quite pricey.

“So, manufacturers may be reluctant to invest in innovative products. Moreover, why would they if present technologies are still good ‘cash-cows’ that generate good profits, and growth markets are still emerging?” he wondered.

He referred to what he called the ‘innovation paradox, where the more disruptive a new product is, the higher is the risk for its timely development, particularly in a market where existing technologies are still very profitable.

Wieringa provided an overview of the main pioneers in this field, like Victor Gura, who he considered the “Charles Lindbergh of wearable dialysis”, having already realized three clinical trials with a wearable hemodialysis device, each time with stepwise improvements.

“But lack of funding hampers progress,” he explained, adding that other breakthrough works for an implantable artificial kidney show systematic progression but also lack significant funding.

The US Food and Drug Administration (FDA) recently estimated the overall cost of development for a complex medical device at $526.4 million after accounting for the cost of failures and the opportunity cost of capital.

Kidney disease research pins hopes on new disruptive technologies

Not many substantial breakthroughs have been experienced in the field of chronic kidney disease (CKD) treatment since the mass diffusion of dialysis units in the ’70s. Technological progress is growing exponentially though, opening up new possibilities for bettering patients’ lives.

Not really ‘portable’ devices

Many patients are already aware of the option of home hemodialysis but do not have a real understanding of what it would mean to dialyse at home. At the same time, current options for portable devices are not that enticing.

Existing home machines are intrusive and take up a lot of space at home, often requiring house refurbishment because they need a water purification system and high power supply.

Furthermore, the state-of-the-art machines are not that flexible, meaning that patients are still bound to their homes and cannot travel for more than two days.

“I have the most ‘portable’ machine on the market and it weighs 45 kilograms when packed to travel by air. That is not really portable,” kidney patient Henning Søndergaard told EURACTIV.

According to him, more portable devices would be not only a good alternative to going to the hospital but also a great advantage over the different home dialysis modalities currently in use.

“Simply put, nobody wants to go to the hospital 3-4 times a week and spend at least four hours in treatment. Dialysis is close to being a ‘full-time job’,” he continued.

The Dutch Kidney Foundation started 10 years ago a project aimed at giving patients a device that would help them to fit their dialysis treatment in their lives.

The Neokidney project consists of a plug-and-play and user-friendly home hemodialysis machine weighing less than 10 kilograms and fitting into a hand-carried suitcase, also using only between 4 and 6 litres of dialysis fluids.

Once developed, the device will be three times smaller and lighter than the smallest home dialysis machine in the market, also operating on any 110/230V power grid.

“This device is the next step beyond home hemodialysis and we will be able to bring dialysis to the patient. Dialyze wherever, whenever,” said John Stooker, CEO of Neokidney, adding that it could be used not only at home but also in small dialysis hubs such as in retirement homes or holiday resorts.

Patient autonomy, education must be priorities for tackling kidney disease

With incidences of kidney disease predicted to soar in the next decade, health stakeholders are calling for more efforts to ensure patient autonomy and invest in training for both practitioners and patients.

*Giedre Peseckyte contributed to the reporting

[Edited by Zoran Radosavljevic]

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